View clinical trials related to Influenza (Healthy Volunteers).
Filter by:This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23. The secondary objectives of the study are: - To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®) - To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS
- To describe the immune response induced by quadrivalent recombinant influenza vaccine (RIV4) and Quadrivalent-inactivated Influenza Vaccine (IIV4) in 18-49 and greater than or equal to (>=) 50 years of age participants by hemagglutination inhibition (HAI) measurement method. - To describe the safety profile of all participants in RIV4 and IIV4 groups.
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22. The secondary objectives of the study are: - To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. - To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. - To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.
Primary Objective: Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants. Safety: To describe the safety profile of all participants in each study groups.
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations. Secondary Objective: - To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of: - inpatient hospitalization for selected circulatory and respiratory causes - death, either all-cause or cardiovascular or respiratory causes - inpatient hospitalization (using primary and secondary discharge diagnoses) - inpatient hospitalization (using admission diagnoses) - hospital emergency room visits - primary care visits to physician or - major acute cardiovascular events (MACE) - To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups. - To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD: - by age group and by group with specific comorbidities - for different periods of observation - To describe all serious adverse events (SAEs) (including adverse event of special interest [AESIs]) for all subjects in both QIV-HD and QIV-SD groups.